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Sponsors and Collaborators: |
ISS, Inc. National Institute of Neurological Disorders and Stroke (NINDS) Carle Foundation Hospital University of Illinois University of California, Irvine |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00591591 |
The goal of this trial is to assess the performance of the OxiplexTS—an absolute near-infrared oximeter—as an instrument to measure brain oxygenation and hemodynamics in sleep medicine as well as in the broader field of cardiovascular/cerebrovascular diagnostics.
Condition | Intervention | Phase |
---|---|---|
Obstructive Sleep Apnea Syndrome |
Device: OxiplexTS |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Parallel Assignment |
Official Title: | Absolute Near-Infrared Brain Oximeter |
Estimated Enrollment: | 300 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
OSA: Experimental
Persons with obstructive sleep apnea
|
Device: OxiplexTS
OxiplexTS is a Frequency Domain Neat-Infrared Tissue oximeter which provides absolute values of tissue oxygen saturation in real time. The instrument also provides other important physiological quantities such as total hemoglobin concentration and the individual concentration of oxy- and deoxy-hemoglobin, which form the basis for the functional relevant measurement for brain hemodynamics. Both the control and OSA groups will undergo standard overnight sleep study (polysomnography). In addition to the standard PSG (with or without Continuous Positive Airway Pressure (CPAP)), the study researchers will add the OxiplexTS, allowing them to assess brain oxygenation and hemodynamics during sleep. The hemodynamic patterns of the healthy controls will be compared to those of the persons with OSA. Participants with OSA who undergo PSG/CPAP will be tested with the OxiplexTS as well. Their PSGs and PSG/CPAP data will be compared. |
Controls: No Intervention
Healthy controls
|
Frequency domain near-infrared spectroscopy (NIRS) offers the advantage of performing safe, non-invasive, transcranial, quantitative measurements of brain oxygenation and hemodynamics in real-time. These characteristics make NIRS the ideal tool to study physiological and pathological processes of the brain, in settings ranging from research and diagnostic laboratories to intensive care units and operating rooms.
Scientists recently developed the first commercially available absolute near-infrared oximeter, called OxiplexTS. This portable device will be used to study brain vascular autoregulatory responses (such as responses to hypoxia and hypercapnia) in persons with obstructive sleep apnea (OSA). These responses to allow for the assessment of brain vascular health. The OxiplexTS device will be beneficial in identifying persons at risk for cerebrovascular disease. Polysomnography (PSG), which is currently used to assess sleep disorders, gives important information on the function of different systems, however, it does not provide information on brain oxygenation and hemodynamics during sleep. The assessment of these factors, via NIRS, in persons with OSA is crucial because of the high prevalence of the disorder and the significant cardio/cerebrovascular health risk it represents.
The specific aim of this trial is to make OxiplexTS a clinically usable instrument, especially for research and clinical diagnosis and monitoring of sleep disorders. An additional goal is to determine the usefulness of this instrument for providing measurements in various clinical situations including intensive care management or prolonged surgical procedures, such as cardiothoracic surgery that require critical information of brain oxygenation and hemodynamics. This trial emerges from previous phase I and phase II studies which determined the feasibility of using OxiplexTS to assess brain vascular autoregulatory responses to hypoxic stimuli.
Approximately 300 participants will be recruited from a pool of healthy individuals, individuals with OSA, and volunteers undergoing overnight diagnostic or therapeutic PSG for suspected OSA.
Participants will be divided into two groups: healthy controls and persons with OSA. Both groups will undergo standard overnight sleep study or PSG.
In addition to the standard PSG (with or without Continuous Positive Airway Pressure (CPAP)), the study researchers will add the OxiplexTS—allowing them to assess brain oxygenation and hemodynamics during sleep. The hemodynamic patterns of the healthy controls will be compared to those of persons with OSA. Participants with OSA who undergo PSG/CPAP will be tested with the OxiplexTS, as well. Their PSG and PSG/CPAP data will be compared.
Ages Eligible for Study: | 21 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Antonios Michalos, M.D., M.S. | 217-359-8681 | antonios.michalos@iss.com |
United States, California | |
University of California-Irvine Sleep Disorders Center, 101 The City Drive South, Bldg. 22C, 2nd Floor, Rt. 23 | Recruiting |
Orange, California, United States, 92868 | |
Contact: Marcel Hungs, MD, PhD 714-456-5105 mhungs@uci.edu | |
Stanford Sleep Disorders Clinic, Psychiatry Building, 401 Quarry Road | Not yet recruiting |
Stanford, California, United States, 94305 | |
Contact: Christian Guilleminault, MD 650-723-6601 cguil@leland.stanford.edu | |
United States, Illinois | |
Center of Sleep and Ventilatory Disorders, University of Illinois Medical Center at Chicago, 2200 W Harrison | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Christopher O. Olopade, MD, MPH 312-996-8039 cosolopa@uic.edu | |
Carle Regional Sleep Disorders Center, Carle Foundation Hospital, 611 West Park Street | Recruiting |
Urbana, Illinois, United States, 61801 | |
Contact: Daniel L. Picchietti, MD 217-383-9138 Daniel.Picchietti@carle.com |
Principal Investigator: | Antonios Michalos, M.D., M.S. | ISS, Inc. |
Responsible Party: | ISS, Inc. ( Antonios Michalos, M.D., M.S./Director of Medical Research, Principal Investigator ) |
Study ID Numbers: | R44NS040597, 2R44NS040597-04, GRANT00130523, RNS040597C |
Study First Received: | December 21, 2007 |
Last Updated: | February 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00591591 History of Changes |
Health Authority: | United States: Federal Government |
Obstructive Sleep Apnea Syndrome sleep disordered breathing polysomnography (psg) continuous positive airway pressure (cpap) |
brain vascular autoregulation brain tissue oxygenation near-infrared spectroscopy Obstructive Sleep Apnea |
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders |
Sleep Apnea, Obstructive Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
Sleep Apnea Syndromes Disease Apnea Sleep Apnea, Obstructive Respiration Disorders Nervous System Diseases Dyssomnias |
Sleep Disorders Sleep Disorders, Intrinsic Signs and Symptoms Pathologic Processes Respiratory Tract Diseases Syndrome Signs and Symptoms, Respiratory |